ISO 17065:Competency requirement for product certification body

Courtesy: ISO 17065:Competency requirement for product certification body

A product might be verified to comply with a specification or stamped with a specification number. This does not, by itself, indicate that the item is fit for any particular use. The person or group of persons who own the certification scheme (i.e., engineers, trade unions, building code writers, government, industry, etc.) have the responsibility to consider the choice of available specifications, choose the correct ones, set qualification limits, and enforce compliance with those limits. The end users of the product have the responsibility to use the item correctly. Products must be used in accordance with their listing for certification to be effective.

Product certification is often required in sensitive industry and marketplace areas where a failure could have serious consequences, such as negatively affecting the health and welfare of the people or person using that product. For example, certification is stringent in aerospace applications, since the demands for low weight tend to lead to high stress on components, requiring appropriate metallurgy and accuracy in manufacturing. Other sensitive product area examples include food, pharmaceuticals, healthcare products, dangerous goods, electrical equipments and products that have RF emissions such as computers and cellular telephones.

The process for certification of a product is generally summed up in four steps:

• Application (including testing of the product)

• Evaluation (does the test data indicate that the product meets qualification criteria)
• Decision (does a second review of the product application concur with the Evaluation)
• Surveillance (does the product in the marketplace continue to meet qualification criteria)

In many instances, prior to applying for certification, a product supplier will send a product to a testing laboratory (some certification schemes require the product to be sent out for testing by the product certifier instead). When the product to be certified is received at the testing laboratory, it is tested in accordance with the laboratory’s internal procedures and with the methods listed in the test standards specified by the certification scheme. The resulting data collected by the testing laboratory, and is then forwarded either back to the manufacturer, or directly to the product certifier.

The product certifier then reviews the product supplier’s application information, including the testing data. If the certifier’s evaluation concludes that the test data shows that the product meets all required criteria as listed in the certification scheme, and the decision maker(s) of the product certifier concur with the evaluation, then the product is deemed “certified” and is listed in a directory that the Product certifier is required to keep. ISO Guide 65 requires that the final decision to grant or not grant certification be made only by a person or group of persons not involved in the evaluation of the product.

Products often need periodic recertification, also known as surveillance. This requirement is typically identified within the certification scheme that the product is certified to. Certification bodies may require product suppliers to perform some sort of surveillance activity, such as pulling sample products from the marketplace for testing, in order to maintain their “listed” or “certified” status. Other examples of Surveillance activities include surprise audits of the manufacturing plant, supervision of the manufacturing and/or testing process, or a simple paperwork submittal from the supplier to the product certifier to ensure that the certified product has not changed. Other causes for recertification may include complaints issued against the product’s functionality, which would require removal from the marketplace, and expiration of the original certification. These lists of examples are by no means all inclusive.